Mark Dewhurst

Experience

• 

  Pfizer Pharmaceuticals

  Nov 1997 - Dec 2001

  Cardiovascular Biologist, Veterinary Medicine
• 

  Pfizer Pharmaceuticals

  May 2002 - Sept 2011

  • Senior Study Director, Global Safety Pharmacology

    Jul 2003 - Sept 2011

  • Senior Scientist, Cardiovascular Biology

    May 2002 - Jul 2003
• 

  Covance

  Jan 2012 - Sept 2013

  Medical Writer (Clinical Regulatory)

  Responsible for writing, and coordinating the development of ICH Good Clinical Practice (GCP) Compliant Clinical Trial Protocols and Clinical Study Reports. Lead scientific writer on pivotal client projects to develop Phase 1 clinical trial protocols, including: - complex proof of concept clinical pharmacology studies- pharmacokinetic and pharmacodynamic studies- investigate safety/tolerability.

• 

  IQVIA

  Sept 2013 - now

  TECHNOLOGY SME Representative on global project teams developing technology platforms to support submission tracking and clinical trial document management, including integration with electronic Trial Master Files and Clinical Trial Management Systems. Key responsibilities include:• Initial scoping of end-user requirements based on business processes, sandbox testing of prototypes, and enhancement identification and prioritisation as member of change control board.• End-user implementation via preparation and delivery of training materials and guides, group and individual colleague mentoring and support, feedback of bugs and system enhancement requests.• Identification and resolution of business process gaps, revision and implementation of process and standard operating procedure changes with stakeholders. • Detailed technical review and feedback of critical configuration data to system development team.REGULATORY ADVISORSupport and completion of clinical trial submissions for multi-national clinical trials on behalf of multiple clients:• Regulatory lead and strategy development on complex multinational clinical trials including preparation of core submission dossiers for global clinical trials.• Resolution of country, client and study team queries relating to clinical trial submissions.• Management, preparation and submission of clinical trial applications to United Kingdom Medicines & Healthcare products Regulatory Agency and European Medicines Agency.• Regulatory medical writing of documents including cover letters, application and amendment forms, informed consent forms and labels. • Technical QC review of pivotal submission documents such as Protocols, Investigator’s Brochures and Investigational Medicinal Product Dossiers.• Ad hoc support of projects such as reformatting and content overhaul of IQVIA portfolio of global Informed Consent Form templates. Show less

  • Regulatory Advisor and Technology SME

    Apr 2015 - now

  • Medical Writer

    Sept 2013 - Apr 2015